NZ company - tissue repair product, page-26

OK. So it seems the people have spoken. Let’s look at your statements of the last few days Tim:
20/10 16.32
“here is a little fact for you. Its the company (not BSI) who nominates what it wants its product listed under.” – Two problems with this statement. Firstly you lack clarity. “listed under” is meaningless. The company determines the “classification” of the device (ie class I, IIa, IIb, or III) and if it is unsure it consults with the notified body (BSI). Secondly, you don’t know what conversations took place between TIS and BSI. You don’t know if it was the company who “nominated” or if BSI gave guidance as to the initial classification. From the announcements at the time however, TIS clearly indicated it was the latter. Therefore you are wrong to state this “little fact”.

“Tis chose (pushed for) rule 8”. Firstly you don’t know this to be the truth and secondly it’s not a “rule” that would have been “pushed for” but a classification. This demonstrates you have a fundamental lack of understanding of the process.

“( BSI said "yea that's fine with us!)” – You must have some exceptional surveillance devices to know what conversations took place. Actually I think you just made that up.

“My cat knew it was never a Rule 8, never in a million years. The EMA know as well, and see it for what it was, as an attempt to get in the back door.” – Again demonstrating your lack of understanding. The EMA did not even follow their own guidelines and tried to find it was not a device at all under any classification. They had no power to do this and had to back down. Having accepted that MHRA has jurisdiction to decide the classification (as they did) the EMA did not even have to turn their mind to what the correct classification was or what rule was used to reach that classification. After all MHRA gave VG the highest classification there was (ie III).

“Trying Rule 8 was an incompetent risk” – That’s just sheer non-sense. TIS arrived at a classification with BSI (who knows who pushed for what). BSI changed their position regarding classification and referred the matter to MHRA. It’s that simple. Correct processes were followed and MHRA classified it as class III. No risk because TIS, BSI and MHRA just followed processes and got to an end result.

20/10 19.33
“Looks to me like someone's twisted the facts here for their benefit” You immediately follow this statement with a quote from MHRA (I presume its not from NRMA) that explains the very process that was followed. How is that twisting of facts? Were you present at any meeting to be able to say that TIS mis-led shareholders on this point? You then go on and conclude your diatribe with a cherry picked quote to try and back up your assertions while ignoring the research you yourself have just done. Perhaps you simply didn’t understand what you were reading??

This is from the Medical Devices: Guidance Document – Classification of Medical Devices: “In case the manufacturer is unsure how its devices should be classified, it should first consult a Notified Body.”

How do you know this isn’t what happened?? Were you there? Your problem Tim is that you make grand leaps of logic and then try to back them up. Your problem is your leaps are just way too big and can’t be supported. Your problem is you find yourself hanging from the ledge and start grabbing at small pieces of information in the hope that you can scrabble your way to safety. Of course you have a right to an opinion but it is a very dangerous exercise to start asserting your beliefs as “facts” without evidence to support them.

Anyway, let’s turn to other matters. I’m hoping for a CE Mark by the end of the year for a product that I believe will bring an end to the pain and suffering of tens of thousands of people.

GLTA
Rev